SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]

  • Home
  • SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]

SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [WAL-MART STORES INC]
PDF | XML
NDC 49035-558-22, 49035-558-42
Set ID 2746d0ad-7e3e-4d6b-a828-246050c2e06c
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
View All Sections
  • Active ingredients (in each gelcap)

    Acetaminophen 325 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
      • headache
      • nasal congestion
      • sinus congestion and pressure
      • minor aches and pains
    • helps decongest sinus openings and passages
    • promotes sinus drainage
    • helps clear nasal passages
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.       

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • heart disease
    • diabetes
    • liver disease
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • high blood pressure

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition. 

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed
    • adults and children 12 years and over
      • take 2 gelcaps every 4 hours
      • do not take more than 10 gelcaps in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid high humidity 
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    corn starch, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, silicon dioxide, stearic acid, titanium dioxide

  • Questions or comments?

    1-888-287-1915

  • Principal Display Panel

    NDC 49035-558-22

    equate™

    Compare to
    Tylenol® SINUS
    + HEADACHE
    Day Active
    Ingredients*

    Rapid Release
    Sinus
    Congestion
    & Pain

    Acetaminophen, Phenylephrine HCl
    Pain Reliever, Fever Reducer, Nasal Decongestant

    Daytime Non-Drowsy

    • Sinus headache & pressure
    • Nasal congestion

    48 GELCAPS

    Actual Size

    TAMPER EVIDENT:
    DO NOT USE IF PACKAGE IS
    OPENED OR IF BLISTER UNIT IS
    TORN, BROKEN OR SHOWS ANY
    SIGNS OF TAMPERING

    Satisfaction guaranteed - 
    Or we'll replace it or give you your
    money back.
    For questions or comments,
    please call 1-888-287-1915.

    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716

    *This product is not manufactured or
    distributed by Johnson & Johnson Corporation,
    owner of the registered trademark Tylenol®
    SINUS + HEADACHE Day.
    50844          REV0418D55822


    Equate 44-558

    Equate 44-558

  • INGREDIENTS AND APPEARANCE
    SINUS CONGESTION AND PAIN  DAYTIME
    acetaminophen and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-558
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    Colorred (red, green and gray in the middle) , greenScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L;8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-558-224 in 1 CARTON03/17/2008
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-558-4212 in 1 BLISTER PACK; Type 0: Not a Combination Product03/17/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/17/2008
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(49035-558)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(49035-558)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(49035-558)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(49035-558)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(49035-558)
View All Sections

Related Drugs

Search DailyMed Drugs